Regulatory Specialist

Job Title: Regulatory Specialist
Location: Rosemont, IL - Remote
Duration: Long Term Contract

Key Responsibilities:

·         Provide strategic input and technical guidance on regulatory requirements to R&D project teams. 

·         Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company.

·         Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality submissions. 

·         Monitor product-related activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices.

·         Review all supporting documentation required in regulatory applications for accuracy and completeness and determine the applicability of supporting documentation for inclusion in regulatory submission. 

·         Keep abreast of additions, changes, and emerging trends to regulations and guidelines and evaluate relevance to company and products.

·         Provide the regulatory perspective on Due Diligence activities in support of potential new business opportunities. Review data/information as needed. 

·         Be familiar with Global regulatory aspects of all the global products; contribute to discussions and regulatory strategies as needed.

·         Establish expertise on guidelines and regulatory requirements for combination products. 

·         Ensure the maintenance of FDA Controlled Correspondences log in an easily searchable format to enable quick reference to resolved issues. 

·         Ensure the maintenance of FDA Information Requests log for A/NDAs in an easily searchable format to provide insight into FDA review trends.

·         Review and oversee the development and/or revision of Standard Operation Procedures as they relate to cGMP quality and regulatory compliance. 

 Required Education and Experience: 

·         BS/BA required in a scientific discipline. 

·         Minimum of 12 years of experience in the pharmaceutical/biotech industry within the Regulatory Affairs/R&D functions. 

·         Deep and broad knowledge of regulatory affairs. 

·         Direct, hands-on experience with pharmaceutical regulatory submissions and product approvals.

·         Experience with post-approval life cycle management of marketed products. 

·         Proven track record of effective collaboration with regulatory agencies, including the FDA 

·         Solid knowledge of cGMP regulations and current industry trends related to pharmaceutical and biological products. 

·         Thorough understanding of the applicable sections of the US Code of Federal Regulations, FDA/ICH guidelines and cGMP''s, as they pertain to pharmaceuticals. 

·         Advanced degree in a scientific discipline preferred 

·         Must be able to serve as the company expert on regulatory affairs.

·         Strong entrepreneurial abilities, sense of urgency, and team player. 

·         Well-developed organizational, interpersonal, and project management skills. 

·         Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions. 

·         Experience with combination products. 

·         Excellent written and verbal communication required.

·         Must be willing to travel.